BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1589210 · Received January 14, 2010

    Report

    Report Number
    2027969-2010-00040
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 14, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USE AT TIME OF COMPLAINT WAS FILED: INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 3.7; 2ND INR: 2.2; 3RD INR: 1.4; MEAN: 2.43; SD: 1.17; %CV: 47.98. MEAN CALCULATIONS FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED ACCURACY TEST IS REQUIRED TO DETERMINE PRODUCT DEFICIENCY. NO PRODUCT WAS EXPECTED TO BE RETURNED. ACCURACY TEST WITH RETAINED STRIP DID NOT REPRODUCE COMPLAINT. (B) (4) FOLLOW-UP COMMUNICATIONS INDICATED THAT SOME TESTS MAY HAVE BEEN DONE 12 HOURS APART. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE ROOT CAUSE OF COMPLAINT. PER GENERAL DESCRIPTION, PATIENT WAS ON LOVENOX. LOVENOX IS A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY." AS OF 01/13/2010, EIGHT DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220392 YIELDING A COMPLAINT RATE OF 0.002%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. INVESTIGATION RESULTS ON RETAINED LOT #220392. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT 220392 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED. (B) (4). FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE OF STRIP LOT 220392, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS WERE 7.69% AND 0%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. CALLER ALLEGED IMPRECISION WITH INRATIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220392

    Patients

    Seq Age Sex Outcome Treatment
    1 NI